Phase I/II study of carboplatin plus nab-paclitaxel and concurrent radiotherapy for patients with locally advanced non–small cell lung cancer

Yuko Kawano, Tomonari Sasaki, Hiroyuki Yamaguchi, Katsuya Hirano, Atsushi Horiike, Miyako Satouchi, Shinobu Hosokawa, Ryotaro Morinaga, Kazutoshi Komiya, Koji Inoue, Yuka Fujita, Ryo Toyozawa, Tomoki Kimura, Kosuke Takahashi, Kazuo Nishikawa, Junji Kishimoto, Yoichi Nakanishi, Isamu Okamoto

Research output: Contribution to journalArticle

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Abstract

Objectives: Chemoradiation regimens of greater efficacy are needed for patients with locally advanced non–small cell lung cancer (NSCLC). Patients and methods: In a phase I study, escalating doses of weekly nab-paclitaxel (40 or 50 mg/m 2 ) were administered along with weekly carboplatin at an area under the curve (AUC) of 2 mg mL –1 min and concurrent radiotherapy with 60 Gy in 30 fractions to patients with locally advanced NSCLC. This concurrent phase was followed by a consolidation phase consisting of two 3-week cycles of nab-paclitaxel plus carboplatin. In a phase II study, nab-paclitaxel was administered at the recommended dose (RD) together with carboplatin and radiation. Results: In the phase I study, one of six patients experienced dose-limiting toxicity (leukopenia of grade 3 requiring a second consecutive skip in the administration of weekly chemotherapy) with nab-paclitaxel at 50 mg/m 2 , which was therefore determined to be the RD. Fifty-six patients treated at the RD were evaluable for safety and efficacy. Common toxicities of grade 3 or 4 in the concurrent phase included leukopenia (60.7%) and neutropenia (28.6%). No treatment-related deaths occurred during the study period. The objective response rate was 76.8% (95% confidence interval [CI], 64.2–85.9%), median progression-free survival was 11.8 months (60% CI, 10.6–16.2 months; 95% CI, 8.2–20.8 months), and median overall survival was not reached. Conclusion: Our results reveal encouraging feasibility and activity for concurrent chemoradiation with nab-paclitaxel at 50 mg/m 2 and carboplatin at an AUC of 2 in patients with locally advanced NSCLC.

Original languageEnglish
Pages (from-to)136-141
Number of pages6
JournalLung Cancer
Volume125
DOIs
Publication statusPublished - Nov 1 2018

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Carboplatin
Non-Small Cell Lung Carcinoma
Radiotherapy
Leukopenia
Confidence Intervals
Area Under Curve
Neutropenia
Disease-Free Survival
130-nm albumin-bound paclitaxel
Radiation
Safety
Drug Therapy
Survival

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Phase I/II study of carboplatin plus nab-paclitaxel and concurrent radiotherapy for patients with locally advanced non–small cell lung cancer. / Kawano, Yuko; Sasaki, Tomonari; Yamaguchi, Hiroyuki; Hirano, Katsuya; Horiike, Atsushi; Satouchi, Miyako; Hosokawa, Shinobu; Morinaga, Ryotaro; Komiya, Kazutoshi; Inoue, Koji; Fujita, Yuka; Toyozawa, Ryo; Kimura, Tomoki; Takahashi, Kosuke; Nishikawa, Kazuo; Kishimoto, Junji; Nakanishi, Yoichi; Okamoto, Isamu.

In: Lung Cancer, Vol. 125, 01.11.2018, p. 136-141.

Research output: Contribution to journalArticle

Kawano, Y, Sasaki, T, Yamaguchi, H, Hirano, K, Horiike, A, Satouchi, M, Hosokawa, S, Morinaga, R, Komiya, K, Inoue, K, Fujita, Y, Toyozawa, R, Kimura, T, Takahashi, K, Nishikawa, K, Kishimoto, J, Nakanishi, Y & Okamoto, I 2018, 'Phase I/II study of carboplatin plus nab-paclitaxel and concurrent radiotherapy for patients with locally advanced non–small cell lung cancer', Lung Cancer, vol. 125, pp. 136-141. https://doi.org/10.1016/j.lungcan.2018.09.014
Kawano, Yuko ; Sasaki, Tomonari ; Yamaguchi, Hiroyuki ; Hirano, Katsuya ; Horiike, Atsushi ; Satouchi, Miyako ; Hosokawa, Shinobu ; Morinaga, Ryotaro ; Komiya, Kazutoshi ; Inoue, Koji ; Fujita, Yuka ; Toyozawa, Ryo ; Kimura, Tomoki ; Takahashi, Kosuke ; Nishikawa, Kazuo ; Kishimoto, Junji ; Nakanishi, Yoichi ; Okamoto, Isamu. / Phase I/II study of carboplatin plus nab-paclitaxel and concurrent radiotherapy for patients with locally advanced non–small cell lung cancer. In: Lung Cancer. 2018 ; Vol. 125. pp. 136-141.
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abstract = "Objectives: Chemoradiation regimens of greater efficacy are needed for patients with locally advanced non–small cell lung cancer (NSCLC). Patients and methods: In a phase I study, escalating doses of weekly nab-paclitaxel (40 or 50 mg/m 2 ) were administered along with weekly carboplatin at an area under the curve (AUC) of 2 mg mL –1 min and concurrent radiotherapy with 60 Gy in 30 fractions to patients with locally advanced NSCLC. This concurrent phase was followed by a consolidation phase consisting of two 3-week cycles of nab-paclitaxel plus carboplatin. In a phase II study, nab-paclitaxel was administered at the recommended dose (RD) together with carboplatin and radiation. Results: In the phase I study, one of six patients experienced dose-limiting toxicity (leukopenia of grade 3 requiring a second consecutive skip in the administration of weekly chemotherapy) with nab-paclitaxel at 50 mg/m 2 , which was therefore determined to be the RD. Fifty-six patients treated at the RD were evaluable for safety and efficacy. Common toxicities of grade 3 or 4 in the concurrent phase included leukopenia (60.7{\%}) and neutropenia (28.6{\%}). No treatment-related deaths occurred during the study period. The objective response rate was 76.8{\%} (95{\%} confidence interval [CI], 64.2–85.9{\%}), median progression-free survival was 11.8 months (60{\%} CI, 10.6–16.2 months; 95{\%} CI, 8.2–20.8 months), and median overall survival was not reached. Conclusion: Our results reveal encouraging feasibility and activity for concurrent chemoradiation with nab-paclitaxel at 50 mg/m 2 and carboplatin at an AUC of 2 in patients with locally advanced NSCLC.",
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T1 - Phase I/II study of carboplatin plus nab-paclitaxel and concurrent radiotherapy for patients with locally advanced non–small cell lung cancer

AU - Kawano, Yuko

AU - Sasaki, Tomonari

AU - Yamaguchi, Hiroyuki

AU - Hirano, Katsuya

AU - Horiike, Atsushi

AU - Satouchi, Miyako

AU - Hosokawa, Shinobu

AU - Morinaga, Ryotaro

AU - Komiya, Kazutoshi

AU - Inoue, Koji

AU - Fujita, Yuka

AU - Toyozawa, Ryo

AU - Kimura, Tomoki

AU - Takahashi, Kosuke

AU - Nishikawa, Kazuo

AU - Kishimoto, Junji

AU - Nakanishi, Yoichi

AU - Okamoto, Isamu

PY - 2018/11/1

Y1 - 2018/11/1

N2 - Objectives: Chemoradiation regimens of greater efficacy are needed for patients with locally advanced non–small cell lung cancer (NSCLC). Patients and methods: In a phase I study, escalating doses of weekly nab-paclitaxel (40 or 50 mg/m 2 ) were administered along with weekly carboplatin at an area under the curve (AUC) of 2 mg mL –1 min and concurrent radiotherapy with 60 Gy in 30 fractions to patients with locally advanced NSCLC. This concurrent phase was followed by a consolidation phase consisting of two 3-week cycles of nab-paclitaxel plus carboplatin. In a phase II study, nab-paclitaxel was administered at the recommended dose (RD) together with carboplatin and radiation. Results: In the phase I study, one of six patients experienced dose-limiting toxicity (leukopenia of grade 3 requiring a second consecutive skip in the administration of weekly chemotherapy) with nab-paclitaxel at 50 mg/m 2 , which was therefore determined to be the RD. Fifty-six patients treated at the RD were evaluable for safety and efficacy. Common toxicities of grade 3 or 4 in the concurrent phase included leukopenia (60.7%) and neutropenia (28.6%). No treatment-related deaths occurred during the study period. The objective response rate was 76.8% (95% confidence interval [CI], 64.2–85.9%), median progression-free survival was 11.8 months (60% CI, 10.6–16.2 months; 95% CI, 8.2–20.8 months), and median overall survival was not reached. Conclusion: Our results reveal encouraging feasibility and activity for concurrent chemoradiation with nab-paclitaxel at 50 mg/m 2 and carboplatin at an AUC of 2 in patients with locally advanced NSCLC.

AB - Objectives: Chemoradiation regimens of greater efficacy are needed for patients with locally advanced non–small cell lung cancer (NSCLC). Patients and methods: In a phase I study, escalating doses of weekly nab-paclitaxel (40 or 50 mg/m 2 ) were administered along with weekly carboplatin at an area under the curve (AUC) of 2 mg mL –1 min and concurrent radiotherapy with 60 Gy in 30 fractions to patients with locally advanced NSCLC. This concurrent phase was followed by a consolidation phase consisting of two 3-week cycles of nab-paclitaxel plus carboplatin. In a phase II study, nab-paclitaxel was administered at the recommended dose (RD) together with carboplatin and radiation. Results: In the phase I study, one of six patients experienced dose-limiting toxicity (leukopenia of grade 3 requiring a second consecutive skip in the administration of weekly chemotherapy) with nab-paclitaxel at 50 mg/m 2 , which was therefore determined to be the RD. Fifty-six patients treated at the RD were evaluable for safety and efficacy. Common toxicities of grade 3 or 4 in the concurrent phase included leukopenia (60.7%) and neutropenia (28.6%). No treatment-related deaths occurred during the study period. The objective response rate was 76.8% (95% confidence interval [CI], 64.2–85.9%), median progression-free survival was 11.8 months (60% CI, 10.6–16.2 months; 95% CI, 8.2–20.8 months), and median overall survival was not reached. Conclusion: Our results reveal encouraging feasibility and activity for concurrent chemoradiation with nab-paclitaxel at 50 mg/m 2 and carboplatin at an AUC of 2 in patients with locally advanced NSCLC.

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